Frequently Asked Questions

Biocore is a pharmaceutical regulatory intelligence infrastructure platform. It provides structured API access to regulatory data from FDA (DailyMed), EMA, PMDA, MHRA, Health Canada, TGA, ANSM, and Swissmedic — 200K+ normalized drug labels across 8 jurisdictions delivered via REST API and webhooks. A Model Context Protocol (MCP) server is in development.

Most developers make their first API call within 5 minutes using Biocore's Quick Start guide. Python and Node.js SDKs are available. Enterprise integration, including GxP validation, typically takes 4–8 weeks.

Biocore's infrastructure is designed to support 21 CFR Part 11 and GxP compliance requirements. It includes audit trails, access controls, electronic signature support, and data provenance tracking. SOC 2 Type II, GxP validation documentation packages (IQ/OQ/PQ), and vendor qualification questionnaires are available for enterprise customers. See biocore.com/compliance for details.

Building your own regulatory data pipeline typically takes 6–18 months and requires a dedicated engineering team. With Biocore's API, you get production-ready access to normalized regulatory data in minutes, not months.

Without Biocore, yes — you need a dedicated team to continuously monitor 8+ regulatory sources across jurisdictions. Biocore manages all ingestion, normalization, and monitoring, so your team focuses on building.

Biocore aggregates data from 16+ primary regulatory sources feeding eight authorities: FDA (via DailyMed), EMA (EPAR), PMDA, Health Canada, TGA, MHRA, ANSM, and Swissmedic. Each source is ingested, normalized into a common schema, and validated before it reaches the API.

Biocore returns all API responses as structured JSON for programmatic use. The same regulatory documents are also available as original-source PDF, web-friendly HTML, and exportable Excel. This lets engineering teams consume normalized fields directly without parsing source documents themselves.

Pharmaceutical and health-technology engineering teams, compliance and pharmacovigilance groups, and AI product teams use Biocore. They share a need for accurate, normalized, multi-jurisdiction regulatory data without dedicating engineers to perpetually maintaining ingestion pipelines across changing agency sources.

Biocore replaces the data-engineering and source-monitoring burden a regulatory affairs team would otherwise carry, delivering normalized, audit-ready data automatically. It does not replace regulatory judgment or strategy; instead it frees regulatory affairs staff to focus on interpretation and decisions rather than collecting and reconciling raw data.

After receiving your API key, send a POST to /v1/search with the apikey header and a JSON body filtering on medicationName. The response returns matching drug labels including medicationName, companyName, lastUpdated, and a productHtml path. Most developers complete this first call in under five minutes.

Schedule a demo with the Biocore team to discuss your integration requirements. After onboarding you receive a test key (bk_test_...) for evaluation and a production key (bk_live_...) for live traffic. No production data is required to start testing against the API.

A basic integration takes minutes: authenticate, query /v1/search, and consume the JSON response. A full production integration with webhooks and multi-jurisdiction coverage typically takes days. Enterprise rollouts that include GxP validation usually run four to eight weeks end to end.

Biocore provides official Python and Node.js SDKs with full OpenAPI documentation, letting you call endpoints with typed helpers instead of building raw requests. Any language can use the REST API directly, and webhook support is included for real-time regulatory change notifications during integration.

Yes. After onboarding you receive a test API key (bk_test_...) rate-limited to 100 requests per day, so you can evaluate search, retrieval, and response shapes against real normalized data before moving to a production key or committing to a pricing proposal.

Biocore covers eight regulatory jurisdictions through a single API: FDA in the United States, EMA in the European Union, PMDA in Japan, Health Canada, TGA in Australia, MHRA in the United Kingdom, ANSM in France, and Swissmedic in Switzerland. All jurisdictions share one normalized data schema.

Biocore provides structured, validated data across 8 jurisdictions (FDA, EMA, PMDA, Health Canada, TGA, MHRA, ANSM, Swissmedic) through a single unified API. Manual comparison across fragmented PDFs and portals is replaced by structured, normalized records.

Yes. Because all eight jurisdictions share one normalized data schema, you can start with a single authority such as FDA and add EMA, PMDA, or others later without re-architecting your integration. Your engagement can scale coverage as your product and regulatory footprint grow.

Yes. Biocore normalizes EMA approval and EPAR data into structured fields you can query programmatically, and webhooks notify you of new European approvals as they occur. This lets commercial and strategy teams monitor EU competitive activity through an API rather than manually reviewing EMA publications.

Biocore helps reconcile drug identifiers by attaching NDC, RxNorm/RxCUI, and UNII codes to its normalized records. Formulary and payer systems use these standard identifiers to match products across data sources accurately, avoiding the mismatches that arise when relying on brand or generic names alone.

Biocore ingests regulatory updates on each source's publication cycle — daily for FDA, EMA, and MHRA; weekly for TGA and Swissmedic; monthly for ANSM, Health Canada, and PMDA. Webhook events fire within hours of any detected change, so downstream compliance and analytics systems reflect the latest available data without manual monitoring of agency portals.

Biocore ingests regulatory updates within 24 hours of publication and dispatches webhook events within hours of detection, giving compliance and engineering teams fast, automated notice of any label change, approval, or safety communication.

Biocore ingests regulatory updates within 24 hours of publication and dispatches webhook events within hours of detecting a change. Compared with manual monitoring that can lag 24–72 hours, this gives compliance and operations teams a meaningful head start on reviewing and responding to regulatory updates.

Monitor FDA label changes automatically by subscribing to Biocore webhooks. When a label changes, Biocore dispatches a structured alert identifying the drug, jurisdiction, and change, usually within hours. This replaces daily manual checks of DailyMed with an event-driven feed your compliance systems can act on immediately.

Yes. Biocore monitors eight jurisdictions — FDA, EMA, PMDA, Health Canada, TGA, MHRA, ANSM, and Swissmedic — and sends unified webhook alerts when any of them publishes a label change, approval, or safety communication, so one integration covers all your regulated markets.

Yes. Biocore integrates with AI agent workflows and LLM pipelines via the Slim API, delivering normalized regulatory data as structured JSON for retrieval and grounding. A Model Context Protocol server is in development and will enable natural-language queries from AI assistants.

Biocore is building a Model Context Protocol server, currently in development, that lets AI assistants query regulatory data in natural language. Until it ships, the Biocore Slim API already delivers structured JSON that integrates cleanly into LLM agent and retrieval workflows today.

Biocore is building a Model Context Protocol server, currently in development, that will let AI assistants query regulatory data in natural language. Until it ships, the Biocore Slim API delivers structured JSON that integrates cleanly into LLM agent and retrieval pipelines today.

Provide regulatory data to an AI agent by calling the Biocore Slim API and feeding its structured JSON into the agent's retrieval context. Because fields are normalized across eight jurisdictions, the agent receives consistent, citable data instead of inconsistent text scraped from PDFs or agency websites.

Biocore grounds LLM answers by supplying normalized, source-traceable regulatory fields the model can cite directly. Instead of hallucinating from loosely parsed labels, an agent retrieves validated drug-label and safety data through the API, improving answer accuracy and giving each response a verifiable regulatory source.

Build a drug information portal by querying the Biocore API for normalized label fields — indications, dosing, warnings, and contraindications — and rendering them in your interface. Webhooks notify your portal when labels change, so displayed information stays current without manual updates or custom DailyMed ingestion.

Biocore provides an FDA drug label API that normalizes DailyMed SPL data into structured JSON. Rather than parsing raw SPL XML, you query clean fields for any drug and receive consistent label content, with the same schema extending to seven additional jurisdictions beyond the FDA.

Keep drug label data current by subscribing to Biocore webhooks, which fire within hours of any label change, new approval, or safety communication. Your portal updates the affected records automatically, so users always see current prescribing information without scheduled re-scraping or manual review of agency sources.

Biocore functions as a pharmacovigilance data source, delivering structured adverse reaction and safety data through its API. Safety teams pull machine-readable signals normalized across eight jurisdictions into their monitoring systems, replacing manual aggregation of inconsistently formatted data from multiple regulatory agencies with a single consistent feed.

Get adverse event regulatory data by querying Biocore for structured safety and adverse reaction fields tied to specific drugs. The data is normalized across jurisdictions, so a pharmacovigilance system receives consistent records rather than reconciling varied formats from FDA, EMA, and other agencies individually.

Yes. Biocore supports ongoing safety surveillance by combining structured adverse-event data with webhook notifications for new safety communications. Pharmacovigilance teams receive timely, machine-readable updates across eight jurisdictions, enabling continuous signal monitoring and supporting regulatory reporting obligations without manual collection from individual agency portals.

Track competitor drug approvals by querying Biocore for approval and label data across eight jurisdictions and subscribing to webhooks for new events. Instead of manually watching multiple agency sites, strategy teams receive structured, timely notifications when competitors gain approvals or update labels in any covered market.

Biocore supports competitive intelligence by delivering normalized approval, label, and safety data across eight jurisdictions through one API. Teams build dashboards and alerts on competitor activity using consistent structured data, replacing slow manual monitoring of fragmented agency sources with a programmatic, multi-market intelligence feed.

Biocore serves as a formulary data source by delivering normalized drug records with standard identifiers such as NDC, RxNorm, and UNII. Health IT and payer teams reconcile products reliably across systems and ground formulary decisions in current, structured regulatory and label data through a single API.

Get drug formulary regulatory data by querying Biocore for normalized label, identifier, and regulatory fields per product. Because records carry NDC, RxNorm, and UNII identifiers, formulary systems match drugs accurately and stay current as labels and approvals change across the eight jurisdictions Biocore covers.

The alternative is licensing normalized regulatory data through an API like Biocore. Instead of spending 6–18 months building ingestion for 16+ sources and maintaining it indefinitely, you consume one normalized schema across eight jurisdictions immediately, redirecting engineering effort toward your actual product.

openFDA offers raw, FDA-only data through a public API with no normalization, multi-jurisdiction coverage, or service-level guarantee. Biocore covers eight jurisdictions in one normalized schema, adds webhooks for real-time change notification, and provides an SLA, making it suited to production systems rather than exploratory queries.

Scraping regulatory sources directly introduces legal risk, constant maintenance as pages change, and no guarantee that data structure stays consistent. Biocore licenses and normalizes the data into a stable schema, so your integration keeps working without rework every time an agency changes its website.

Building in-house carries standing costs across engineering and regulatory-affairs headcount for the initial build, continuous maintenance as 16+ sources change formats, and compliance validation. Biocore replaces those recurring personnel and infrastructure costs with a single managed subscription priced per engagement.

Building carries risks of schema drift, silent data breakage, missed regulatory updates, and validation gaps, all requiring dedicated staff. Buying through Biocore shifts those risks to managed infrastructure with normalization, monitoring, webhooks, and audit-ready data, while your team retains control of how the data is used.

Yes. Biocore's platform supports 21 CFR Part 11 compliance requirements including electronic records and electronic signature controls. The platform includes audit trails, access controls, and validation documentation packages to support pharma compliance teams.

Yes. Biocore provides GxP validation documentation including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation packages. These are available to enterprise customers to support vendor qualification under GxP requirements.

Yes. Biocore maintains a SOC 2 Type II audit report covering security, availability, and processing integrity. The report is available to enterprise customers under NDA upon request. Contact the Biocore compliance team, and the report is typically delivered within five to seven business days.

Biocore captures immutable, timestamped audit trails for all data access and API calls, with user attribution, action type, and timestamps. These trails support 21 CFR Part 11 and ALCOA+ requirements. Enterprise customers can export audit logs for inspection readiness and internal compliance reviews.

Biocore provides IQ, OQ, and PQ protocol templates, a validation summary report template, change control notifications, and a 21 CFR Part 11 feature matrix. Enterprise customers receive a vendor qualification package including the SOC 2 Type II report and security questionnaire responses.

Biocore offers data residency options to meet GDPR and regional data-sovereignty requirements, including EU-hosted deployment for customers processing EU personal data. Contact the Biocore team during onboarding to configure residency for your jurisdiction.

Enterprise customers can request SOC 2 Type II reports, GxP validation documentation, and vendor qualification questionnaires by contacting [email protected] with the subject line 'Compliance Documentation Request'. Most documentation is provided within 5–7 business days.

Biocore follows a 72-hour breach notification protocol aligned with GDPR requirements. In the event of a confirmed breach, Biocore notifies affected enterprise customers within 72 hours with incident details, affected data scope, and remediation steps. A dedicated security response team manages all incidents.

Biocore pricing is scoped per engagement rather than published as a fixed self-serve rate. A proposal is shaped around your deployment option, jurisdictions, integration scope, compliance requirements, and support level, then delivered after a short demo so the quote reflects how your team actually intends to use the platform.

Yes. After onboarding you receive a test API key that lets you evaluate search, retrieval, and response formats against real normalized regulatory data before committing. This sandbox access exists so engineering teams can validate the integration technically before any pricing proposal is finalized.

Enterprise support includes a defined service-level agreement, prioritized technical assistance, and access to compliance documentation such as SOC 2 Type II reports and GxP validation packages. Integration guidance and change-notification support for regulatory source updates are also included, with specifics confirmed in your engagement proposal.

Schedule a demo or email [email protected] to start a quote. During the conversation the Biocore team reviews your deployment preference, required jurisdictions, integration scope, and compliance needs, then returns a tailored proposal so the price reflects your specific use case rather than a generic tier.

Yes. Biocore offers both managed hosting and self-hosted deployment. Self-hosting gives your organization full control over infrastructure and complete data sovereignty, while managed hosting removes infrastructure overhead with automatic updates and high availability. The right option depends on your compliance and operational requirements.

Contract terms are agreed as part of your engagement rather than fixed publicly, because deployment model, jurisdiction coverage, and support level vary by customer. The Biocore team discusses term length during the proposal stage so commitments align with your rollout timeline and procurement constraints.

Your API contract and data schema remain stable when you change plans, so adjusting deployment model, jurisdictions, or support level does not require rewriting your integration. The Biocore team coordinates any transition to keep credentials, endpoints, and webhook configuration working without disruption to your systems.